Bizengri
zenocutuzumab · HER2 x HER3Cynomolgus monkey only
Columvi: which tox species, and why?
glofitamab · CD20 x CD3
Species
Cynomolgus monkey only
“The cynomolgus monkey is a relevant species for toxicology studies based on glofitamab binding to CD20 and CD3 on cynomolgus monkey B- and T-cells.”
Why that species
Comparable binding to human and monkey B- and T-cells (EC50 4.3/2.3 nM B, 21.1/13.2 nM T); no rodent, dog, minipig cross-reactivity
“Glofitamab bound to human and monkey B-cells with EC50 values of 4.3 and 2.3 nM respectively and bound to human and monkey T-cells with EC50 values of 21.1 and 13.2 nM respectively. This justified use of the cynomolgus monkey for general toxicology studies.”
Surrogate molecule
No surrogate; clinical molecule tested in monkey (obinutuzumab pretreatment used in some studies)
“The cynomolgus monkey is a relevant species for toxicology studies based on glofitamab binding to CD20 and CD3 on cynomolgus monkey B- and T-cells.”
Same question, other bispecifics
Blincyto
blinatumomab · CD19 x CD3Chimpanzee (only relevant species, limited non-terminal studies) plus mouse with murine surrogate
Elrexfio
elranatamab · BCMA x CD3Cynomolgus monkey only
Epkinly
epcoritamab · CD20 x CD3Cynomolgus monkey only
Hemlibra
emicizumab · FIXa x FXCynomolgus monkey only
Imdelltra
tarlatamab · DLL3 x CD3Cynomolgus monkey (pivotal); mouse surrogate muS757 for EFD and 1-month study
Kimmtrak
tebentafusp · CD3 x gp100 (TCR fusion)No relevant species; in vitro human cell/tissue assays only
Korjuny
catumaxomab · EpCAM x CD3No relevant species; limited single-dose mouse, rat, one cynomolgus; BiLu mouse surrogate
Lunsumio
mosunetuzumab · CD20 x CD3Cynomolgus monkey only
Lynozyfic
linvoseltamab · BCMA x CD3Cynomolgus monkey only
Ordspono
odronextamab · CD20 x CD3Cynomolgus monkey only
Removab
catumaxomab · EpCAM x CD3No relevant species; in vitro human cells plus mouse surrogate (BiLu); limited single-dose rodent/monkey
Rybrevant
amivantamab · EGFR x METCynomolgus monkey only
Talvey
talquetamab · GPRC5D x CD3Cynomolgus monkey only (tool molecule for pivotal tox); no rodent tox
Tecvayli
teclistamab · BCMA x CD3Cynomolgus monkey only (rabbit used for SC local tolerance only)
Vabysmo
faricimab · VEGF-A x Ang-2Cynomolgus monkey only for pivotal tox (rabbit dropped after early studies)
Ziihera
zanidatamab · HER2 x HER2 (biparatopic)Cynomolgus monkey only